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Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry.
Rev Esp Enferm Dig 2014; 106(4):246-54RE

Abstract

OBJECTIVES

The hepatotoxic potential of statins is controversial. The objectives of this study were to describe the relative frequency of hepatotoxicity caused by statins and the phenotypes found in Spain.

PATIENTS AND METHODS

The incidence of hepatotoxicity attributed to statins in the Spanish Hepatotoxicity Registry (REH) were studied and compared with those attributed to other drugs.

RESULTS

Between April 1994 and August 2012, the REH included a total of 858 cases of which 47 (5.5 %) were attributed to statins. Of these, 16 were due to atorvastatin (34 %); 13 to simvastatin (27.7 %); 12 to fluvastatin (25.5 %); 4 to lovastatin (8.5 %) and 2 to pravastatin (4.3 %). Statins represented approximately half of the cardiovascular group which occupied 3rd place (10 %), after anti-infectious agents (37 %) and central nervous system drugs (14 %). The hepatocellular pattern was predominant, especially in the simvastatin group (85%), the cholestatic/mixed pattern was more frequent with fluvastatin (66 %) and had a similar distribution to atorvastatin. Patients with statin-induced toxicity were older (62 years versus 53 years, p < 0.001) and more often demonstrated anautoimmune hepatitis phenotype (8.5 % versus 1.4 %, p < 0.003).

CONCLUSIONS

Statins are not a common cause of hepatotoxicity in Spain. Atorvastatin is the statin involved in the greatest number of incidents. The liver injury pattern varies among the different statins. The hepatitis phenotype with autoimmune features appears to be a characteristic signature of statin-induced hepatotoxicity.

Authors

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Pub Type(s)

Journal Article

Language

eng

PubMed ID

25075655

Citation

Perdices, E V., et al. "Hepatotoxicity Associated With Statin Use: Analysis of the Cases Included in the Spanish Hepatotoxicity Registry." Revista Espanola De Enfermedades Digestivas : Organo Oficial De La Sociedad Espanola De Patologia Digestiva, vol. 106, no. 4, 2014, pp. 246-54.
Perdices EV, Medina-Cáliz I, Hernando S, et al. Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry. Rev Esp Enferm Dig. 2014;106(4):246-54.
Perdices, E. V., Medina-Cáliz, I., Hernando, S., Ortega, A., Martín-Ocaña, F., Navarro, J. M., ... Andrade, R. J. (2014). Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry. Revista Espanola De Enfermedades Digestivas : Organo Oficial De La Sociedad Espanola De Patologia Digestiva, 106(4), pp. 246-54.
Perdices EV, et al. Hepatotoxicity Associated With Statin Use: Analysis of the Cases Included in the Spanish Hepatotoxicity Registry. Rev Esp Enferm Dig. 2014;106(4):246-54. PubMed PMID: 25075655.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Hepatotoxicity associated with statin use: analysis of the cases included in the Spanish Hepatotoxicity Registry. AU - Perdices,E V, AU - Medina-Cáliz,I, AU - Hernando,S, AU - Ortega,A, AU - Martín-Ocaña,F, AU - Navarro,J M, AU - Peláez,G, AU - Castiella,A, AU - Hallal,H, AU - Romero-Gómez,M, AU - González-Jiménez,A, AU - Robles-Díaz,M, AU - Lucena,M I, AU - Andrade,R J, PY - 2014/7/31/entrez PY - 2014/7/31/pubmed PY - 2015/9/15/medline SP - 246 EP - 54 JF - Revista espanola de enfermedades digestivas : organo oficial de la Sociedad Espanola de Patologia Digestiva JO - Rev Esp Enferm Dig VL - 106 IS - 4 N2 - OBJECTIVES: The hepatotoxic potential of statins is controversial. The objectives of this study were to describe the relative frequency of hepatotoxicity caused by statins and the phenotypes found in Spain. PATIENTS AND METHODS: The incidence of hepatotoxicity attributed to statins in the Spanish Hepatotoxicity Registry (REH) were studied and compared with those attributed to other drugs. RESULTS: Between April 1994 and August 2012, the REH included a total of 858 cases of which 47 (5.5 %) were attributed to statins. Of these, 16 were due to atorvastatin (34 %); 13 to simvastatin (27.7 %); 12 to fluvastatin (25.5 %); 4 to lovastatin (8.5 %) and 2 to pravastatin (4.3 %). Statins represented approximately half of the cardiovascular group which occupied 3rd place (10 %), after anti-infectious agents (37 %) and central nervous system drugs (14 %). The hepatocellular pattern was predominant, especially in the simvastatin group (85%), the cholestatic/mixed pattern was more frequent with fluvastatin (66 %) and had a similar distribution to atorvastatin. Patients with statin-induced toxicity were older (62 years versus 53 years, p < 0.001) and more often demonstrated anautoimmune hepatitis phenotype (8.5 % versus 1.4 %, p < 0.003). CONCLUSIONS: Statins are not a common cause of hepatotoxicity in Spain. Atorvastatin is the statin involved in the greatest number of incidents. The liver injury pattern varies among the different statins. The hepatitis phenotype with autoimmune features appears to be a characteristic signature of statin-induced hepatotoxicity. SN - 1130-0108 UR - https://www.unboundmedicine.com/medline/citation/25075655/Hepatotoxicity_associated_with_statin_use:_analysis_of_the_cases_included_in_the_Spanish_Hepatotoxicity_Registry_ L2 - http://www.grupoaran.com/mrmUpdate/lecturaPDFfromXML.asp?IdArt=4620896&amp;TO=RVN&amp;Eng=1 DB - PRIME DP - Unbound Medicine ER -